Evaluate Safety & Immunogenicity of 2 or 3 Doses of GSK HRV Vaccine in Healthy Infants in South Africa
Phase 2
Completed
- Conditions
- Infections, Rotavirus
- Registration Number
- NCT00383903
- Lead Sponsor
- GlaxoSmithKline
- Brief Summary
The purpose of this study is to determine the appropriate regimen of GSK HRV vaccine for concomitant administration with EPI vaccines to infants in South Africa.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 472
Inclusion Criteria
- Healthy infants born after a normal gestation period (>=36 weeks), between 5 and 10 weeks of age at Dose 1 with confirmed negative HIV status of the subject's mother.
- Written informed consent was obtained from the parent/guardian of the subject before study entry.
Exclusion Criteria
- History of allergic disease/polio disease,
- Confirmed or suspected immunosuppressive or immunodeficient condition,
- Clinically significant history of chronic gastrointestinal disease or other serious medical condition as determined by the investigator,
- Received treatment prohibited by the protocol.
- Any confirmed or suspected immunosuppressive or immunodeficient condition, including human immunodeficiency virus (HIV) infection.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Seroconversion after HRV vaccination
- Secondary Outcome Measures
Name Time Method shedding, serum anti-rota IgA antibody concentrations, anti-polio 1, 2 and 3 seroprotection rates, reactogenicity, safety
Related Research Topics
Explore scientific publications, clinical data analysis, treatment approaches, and expert-compiled information related to the mechanisms and outcomes of this trial. Click any topic for comprehensive research insights.
What are the molecular mechanisms of GSK's live attenuated HRV vaccine in eliciting immune responses against rotavirus strains in infants?
How does the immunogenicity of GSK HRV vaccine compare to other oral rotavirus vaccines like RotaTeq and Rotarix in low-resource settings?
Which biomarkers correlate with protective immunity after administration of GSK HRV vaccine in South African infants?
What adverse events were observed in NCT00383903 and how do they compare to placebo groups in similar phase II trials?
Are there combination approaches involving GSK HRV vaccine and other EPI vaccines that enhance immune response without increased reactogenicity?
Trial Locations
- Locations (1)
GSK Investigational Site
🇿🇦Sunnyside, Pretoria, South Africa
GSK Investigational Site🇿🇦Sunnyside, Pretoria, South Africa